Effects of Healing Touch on Patients Undergoing Hematopoietic Stem Cell Transplant
調査の概要
詳細な説明
Primary Objectives:
I. To estimate the effects of healing touch (HT) vs usual care in the following clinical outcomes of stem cell transplant (SCT) patients; length of hospital stay, days to engraftment, and number of hospital readmissions during 100 days post-transplant.
II. To estimate changes in quality of life (QoL) which occur during hospitalization of SCT patients who receive HT vs. usual care.
III. To examine differences in effects of HT vs. usual care (UC) in patients receiving related allogeneic (Allo) transplant compared to those receiving autologous (Auto) transplant.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive daily HT sessions comprising pain drain, chakra connection, magnetic clearing, and mind clearing over 30 minutes from day 1 until 2 days before discharge from the hospital.
ARM II: Patients receive routine nursing care from doctors and nurses from day 1 until 2 days before discharge from the hospital.
After completion of study treatment, patients are followed up for 100 days.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Iowa
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Iowa City、Iowa、アメリカ、52242
- University Of Iowa Hospitals And Clinics
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Currently undergoing autologous (auto) or related allogeneic (related allo) stem cell transplantation
- Admitted to the University (U) Adult Blood and Bone Marrow Transplant Unit (UIBMTU) of the University of Iowa Hospitals and Clinic
- Ability to provide written informed consent obtained prior to participation in the study and able to complete questionnaires
- Pregnant woman who are eligible for stem cell transplant are included in this study
Exclusion Criteria:
- Patients with any significant history of non-compliance to medical regimens, with inability to grant a reliable informed consent or unable to complete questionnaires
- Patients with evidence of a significant psychiatric disorder by history that would prevent completion of the study will not be allowed to participate, i.e., schizophrenia, anxiety disorder, major depressive disorder and bipolar disorder
- Diagnosis of dementia or other disease affecting cognitive function
- Nursing women are excluded
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Arm 1 (healing touch)
Patients receive daily HT sessions comprising pain drain, chakra connection, magnetic clearing, and mind clearing over 30 minutes from day 1 until 2 days before discharge from the hospital (therapeutic touch). Interventions: therapeutic touch, quality-of-life assessment, and questionnaire administration |
補助研究
補助研究
他の名前：
receiving healing touch
他の名前：
|
|
アクティブコンパレータ：Arm II (usual care)
Patients receive routine nursing care from doctors and nurses from day 1 until 2 days before discharge from the hospital. Interventions: quality-of-life assessment, and questionnaire administration |
補助研究
補助研究
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Length of hospital stay, Days to engraftment defined as absolute neutrophil count (ANC: segs + bands) greater
時間枠：Up to 100 days
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Up to 100 days
|
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Changes in QoL (POMS-SF, FACT-BMT, CES-D)
時間枠：Baseline up to 100 days
|
Changes in levels of QoL measures before and after hospitalization will be compared using the paired t-test or the nonparametric paired sign test, if the assumption of normality is substantially violated.
|
Baseline up to 100 days
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Number of hospital readmissions
時間枠：Up to 100 days
|
Up to 100 days
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Susan K Lutgendorf, PhD、University of Iowa
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。